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OpenTrials
Completed

NCT Number: NCT01447667

Magnetic Resonance Elastography (MRE) as a Predictor of HCC Recurrence After Radiofrequency Ablation (RFA)

The purpose of this study is to determine:

* The efficacy of MRE score as a predictor of HCC recurrence within 2 years after RFA treatment * The efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis

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Key information

About this study

To evaluate whether MRE score reflecting hepatic fibrosis can predict the recurrence of HCC within 2 years after RFA treatment

  • Local recurrence/intrahepatic distant recurrence
  • Multivariable analysis including several related factors to find whether MRE score is an independent predictor of HCC recurrence even after adjusting other factors (etiology of liver disease, size of HCC, vessel invasion, HBsAg titer, etc.)

To find the efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed as single hypervascular hepatocellular carcinoma initially
  • AJCC stage I HCC
  • Child-Pugh class A
  • Planning radiofrequency ablation for HCC
  • Voluntary agreement for this study

Exclusion criteria

  • Decreased kidney function (GFR < 70 mL/min/kg)
  • Contraindication to MRI (pacemaker, defibrillator)
  • Contrast media hypersensitivity
  • Other primary malignancy
  • Acute viral hepatitis
  • Prior history of liver transplantation
  • Thrombosis in splenic vein or portal vein
  • Patients who were enrolled to other clinical trials within 4 weeks
  • Other severe chronic disease or psychiatric disease
  • Pregnant or milk-feeding women
  • Patients with coagulopathy, high risk of bleeding for the liver biopsy
  • Patients who disagree to participate in this study

Treatment and study plan

Magnetic Resonance Elastography

Procedure

Magnetic resonance elastography before RFA and Liver biopsy of 2 HCC tissue and 2 non tumor liver parenchyma tissue

Primary outcomes

  1. Number of patients who experienced HCC recurrence after RFA

    Time frame: within 2 years after RFA procedure

    To see whether MRE score reflecting hepatic fibrosis predicts the recurrence of HCC within 2 years after RFA treatment

Secondary outcomes

  1. Sensitivity and specificity of each indicator of hepatic fibrosis compared to the gold-standard histology score

    Time frame: 2 years after RFA

    To find efficacy of each indicator (MRE, noninvasive serum markers such as APRI, P2/MS) compared to the gold-standard histology score in predicting hepatic fibrosis

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Magnetic Resonance Elastography Score Reflecting Hepatic Fibrosis as an Independent Predictor for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation Therapy

Acronym: MRE

Important dates

Study start
2011
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2011
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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